Senior Medical Writer at Excelya producing scientific content and ensuring compliance in medical deliverables. Collaborating with teams to deliver training and support in medical affairs.
About the role
- Senior Medical Writer authoring and coordinating clinical documents for a biopharma company. Ensuring data integrity and quality of diverse regulatory submissions.
Responsibilities
- Completes assignments independently or for more complex documents, under guidance of a mentor
- Authors a range of clinical documents, including regulatory documents following defined templates
- Ensures high integrity of data interpretation, following negotiation with document team.
- Ensures the consistency and quality level of all documents that are issued.
- Actively participates in all planning, coordination and review meetings.
- Ability to work on 2-3 assignments simultaneously.
- Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team.
Requirements
- Up to 5 years in clinical and regulatory writing experience in the pharmaceutical industry
- Master’s degree or higher in life sciences, pharmacy, medicine or a related scientific discipline.
- Demonstrated experience in preparing clinical regulatory documents (CSRs, clinical summaries and overviews).
- Good understanding of clinical trial design, data analysis and interpretation of safety and efficacy results.
- Strong written and verbal English communication skills.
- Comfortable working in a complex matrix environment and managing multiple priorities.
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
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